Non-invasive Brain Stimulation in Patients With Methamphetamine Use Disorder

NCT05535101 | Unknown

• 1 other identifier: 111-019-F
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to apply the intermittent theta burst transcranial magnetic stimulation (iTBS) treatment and evaluate the effect in improving craving, affective symptoms, and cognitive function for those participants in the community with amphetamine use. An electroencephalography and blood biomarkers will also be examined to explore the possible mechanisms.

Conditions

Craving; Depression, Anxiety; Amphetamine Addiction

Keywords

Addiction; amphetamine; non-invasive theta burst stimulation

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale (Taiwanese version)

  Respondents will specify their level of craving from none to extreme on a 100 mm line (score: 0-10) in each questionnaires, and there are nine questionnaires related to craving.

  Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16

Secondary Outcomes (6)

• The Beck depression inventory (Taiwanese version BDI)

  Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16

• The Beck anxiety inventory (Taiwanese version BAI)

  Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16

• Cognitive function

  Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16

• Tolerance

  Post intervention everytime (8 times total)

• blood biomarkers

  Baseline(Week 0, before intervention), Week 4(after iTBS program), Week 8, Week 16

Study Arms (2)

theta burst stimulation

EXPERIMENTAL

Those participants to receive 1-3 sessions in a single day at an interval of 15 minutes(at least), and 5 high-frequency iTBS sessions per week in total four weeks. Each session: 600-900 pulses with 120-100% resting motor threshold.

Device: Intermittent theta burst transcranial magnetic stimulation (iTBS)

Sham arm

SHAM COMPARATOR

Sham stimulation was delivered using the same protocol as active stimulation, but with the TMS coil rotated by 90 degrees with the edge of the coil touching the scalp.

Device: Sham stimulation

Interventions

Intermittent theta burst transcranial magnetic stimulation (iTBS) DEVICE

The amphetamine users will undergo a one-month iTBS intervention. From Week 1 to Week 4, subjects will be treated five times a week.

theta burst stimulation

Sham stimulation DEVICE

Sham stimulation was delivered using the same protocol as active stimulation, but with the TMS coil rotated by 90 degrees with the edge of the coil touching the scalp.

Sham arm

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ranged 20-65.
• Diagnosis as amphetamine use disorder by clinical psychiatrist according to DSM-V

You may not qualify if:

• Major disorders other than substance use disorders in Diagnostic and Statistics Manual-5 (e.g. Schizophrenia, organic brain syndrome, and bipolar disorders).
• Epilepsy, head trauma, migraine, cardiovascular comorbidity, atypical parkinsonian disorder
• patients with heart pacemakers, implanted drug delivery aids, artificial electronic ears, implantable defibrillators, and/or implanted nerve stimulators, and near the implants mentioned above.
• patients with metal implants above the chest.
• people who have damaged skin in areas of the patient's body that receive stimulation.
• patients with multiple sclerosis.
• patients who have extensive ischemic scarring.
• pregnant women.
• patients with a family history of spasms/epilepsy
• patients taking medications that may lower the seizure threshold.
• patients with severe sleep disorders related to previous rTMS treatment.
• patients with severe heart disease
• patients with intracranial stress caused by uncontrollable migraines.
• people who have been evaluated by a physician as unfit to participate in clinical trials.

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch: lead
• National Health Research Institutes, Taiwan: collaborator

MeSH Terms

Conditions

Depression; Anxiety Disorders; Amphetamine-Related Disorders; Behavior, Addictive

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior

Study Officials

• Cheng-Che Chen, MD, MSc

  Physician, Department if Psychiatry, National Taiwan University Hospital Hsin-Chu branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng-Che Chen, MD, MSc

CONTACT

0972654912; hugocc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: September 10, 2022
• Study Start: September 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: September 10, 2022

Record last verified: 2022-04